Protocol summary

Study aim
Determining the effect of group hope therapy on the quality of life of elderly women with type 2 diabetes in Mostafavian Diabetes Clinic in 1402
Design
According to the inclusion criteria, 40 elderly women with diabetes were selected to participate in the study. Allocation of samples to intervention and control groups was by random block method. Then, through random allocation 2 statistical software, the samples were randomized into 10 blocks of 4 people. The patient number and group name were placed in the envelope and people opened the envelope according to their arrival and the type of group was determined.
Settings and conduct
The researcher explains how hope grows and the necessity of its existence and its effect on despair, depression and feelings of emptiness. Each client tells their own life story. The purpose of this meeting is to help members find hope. It is tried to identify some of the past hopes and successes of the members in order to identify the cause and the paths of these successes. People are encouraged to choose the right goals and bring up the characteristics of the right goals, and the goal in this meeting and the previous two meetings is to increase hope in the members and help the members to increase it after the end of hope.
Participants/Inclusion and exclusion criteria
female Age over 60 years Definitely suffering from type 2 diabetes
Intervention groups
The control group received the center's routine services for 4 weeks, and the intervention group (two groups of ten people) received 8 sessions of 90 minutes (2 sessions per week with an interval of two days) under the supervision of the first project manager (a master's student in psychiatry trained in hope therapy) received the hope therapy program that was designed based on the protocol of Schneider (1999).
Main outcome variables
quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240130060857N1
Registration date: 2024-03-03, 1402/12/13
Registration timing: retrospective

Last update: 2024-03-03, 1402/12/13
Update count: 0
Registration date
2024-03-03, 1402/12/13
Registrant information
Name
Yadollah Jannati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 9808
Email address
y.jannati@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-15, 1402/05/24
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
2023-08-17, 1402/05/26
Actual recruitment end date
2023-10-22, 1402/07/30
Trial completion date
2023-11-06, 1402/08/15
Scientific title
The Effect Of Group Hope Therapy On The Quality Of Life Of Elderly Women With Type 2 Diabetes
Public title
The Effect Of Group Hope Therapy On The Quality Of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female Age 60 years and older Definitely suffering from type 2 diabetes At least one year has passed since the diagnosis of the disease Lack of physical consequences related to diabetes such as: amputation, kidney failure, blindness No use of psychoactive drugs Not suffering from cognitive problems (scoring 7 or higher in the AMT test) Ability to communicate Obtaining a score of 15-45 (on a scale of 15-75) from the quality of life tool of Thomas diabetic patients
Exclusion criteria:
Inability to participate in meetings Having an acute physical or mental illness
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
More than 1 sample in each individual
Number of samples in each individual: 40
44
Actual sample size reached: 40
More than 1 sample in each individual
Actual sample size in each individual: 40
Description of the sample per participant
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Statistical consultant who is responsible for data analysis
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Nasiba Sari School of Nursing and Midwifery. Wasal St. Amir Mazandarani Blvd. Mazandaran Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.MAZUMS.REC.1402.301

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
quality of life
Timepoint
in three stages; Before the intervention, the end of 8 intervention sessions and one month after the end of the intervention
Method of measurement
Thomas quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: includes group hope therapy training.The researcher explains how hope grows and the necessity of its existence and its effect on despair, depression and feelings of emptiness. Each client tells their own life story. The goal is to help members find hope. An attempt is made to identify some of the members' past hopes and successes in order to identify the causes and pathways of these successes. People are encouraged to choose appropriate goals and the goal in this intervention is to give hope to the members.Solutions to create and maintain the factor are proposed and people are asked to engage in positive self-talk and mental imagination. In this meeting, the goal is to maintain hope in the members of the group.
Category
Lifestyle

2

Description
Control group:No intervention is done for the control group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafavian Diabetes Clinic
Full name of responsible person
Dr. Zahra Kashi
Street address
Amir Mazandarani St. Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3337 8789
Fax
+98 11 3337 8789
Email
dmrc@mazums.ac.ir
Web page address
https://dirc.mazums.ac.ir/?AspxAutoDetectCookieSupport=1

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahim Nejad
Street address
Vice President of Research and Technology. Teacher's Square Sari, Mazandaran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
pajhooheshi@mazums.ac.ir
Web page address
https://research.mazums.ac.ir/?AspxAutoDetectCookieSupport=1
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Yadollah Jannati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
psychiatric nursing
Street address
Nasibah Sari Nursing and Midwifery College. Wasal Street Amir Mazandarani St. Sari, Mazandaran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3336 7343
Fax
Email
jannati.yadollah@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Yadollah Jannati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibah Sari Nursing and Midwifery College. Wasal Street Amir Mazandarani St. Sari, Mazandaran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3336 7343
Fax
Email
jannati.yadollah@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Yadollah Jannati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibah Sari Nursing and Midwifery College. Wasal Street Amir Mazandarani St. Sari, Mazandaran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3336 7343
Fax
Email
jannati.yadollah@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
2024
To whom data/document is available
All university people
Under which criteria data/document could be used
Their membership in a scientific institution should be confirmed and they should have an official request from the institution
From where data/document is obtainable
jannati.yadollah@gmail.com
What processes are involved for a request to access data/document
It will be done through email correspondence
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